Assessment of effectiveness and safety of a 3rd dose of mRNA vaccine in kidney transplant recipients.

Phase 1

Conditions: SARS-CoV-2 infection in kidney transplant recipients
safety, effectiveness and immunogenicity of 3rd dose of SARS-CoV-2 mRNA vaccine.
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2022-000319-30-CZ

Lead Sponsor: Institut Klinické a Experimentální Medicíny

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

- Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM)
- vaccinated with 2 doses of BNT162b2
- immunosuppressive regimen includes mycophenolic acid or mycophenolate mofetil
- COVID naive and/or COVID survivors
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- age < 18 years
- pregnant women, breastfeeding women
- unable/unwilling to give informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate safety, immunogenicity and effectiveness of booster dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients;Secondary Objective: Not applicable;Primary end point(s): - SARS-CoV-2 PCR positivity after 3rd dose of SARS-CoV-2 mRNA vaccine<br>- adverse events after 3rd dose of SARS-CoV-2 mRNA vaccine;Timepoint(s) of evaluation of this end point: SARS-CoV-2 PCR test positivity is being mandatorily reported to government run registry (ISIN), hence the timepoint of evaluation is every day from D0 to M12.<br><br>Adverse events are assessed by phone or e-mail during 2-4 weeks after administration of the third dose.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - development and/or change of antiHLA antibodies<br>- development and/or change of anti-SARS-CoV-2 antibodies<br>- development and/or change of cellular anti-SARS-CoV-2 immune response;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months after 3rd dose of SARS-CoV-2 mRNA vaccine